Statement of Work for ClinicalTrials.gov.pdf

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Operations, Maintenance, and Modernization Support for ClinicalTrials.gov

STATEMENT OF WORK

TITLE: Operations, Maintenance, and Modernization Support for ClinicalTrials.gov

1.0 PURPOSE

The purpose of this requirement is to acquire complex professional specialized expertise, some of which is Information Technology (IT) services, to support the operations, maintenance, and modernization of ClinicalTrials.gov.

The primary focus of this requirement is to supplement scientific staff tasked with reviewing the data submitted for trials registered and results information with scientific accuracy as required by law. In addition, this requirement is to acquire and maintain IT expertise for operating the

Protocol Registration and Results System (PRS) database and public website supporting the search of these trials.

This Statement of Work (SOW) describes requirements for software design and engineering, system administration, and other ancillary IT support for ClinicalTrials.gov. Software and systems support is required for the continued growth and evolution of the ClinicalTrials.gov databases and information systems to accommodate the flow of protocol registrations and results submissions. The National Center for Biotechnology Information (NCBI) of the National

Library of Medicine (NLM) has a critical requirement for this support in order to re-engineer key system components to improve performance, reliability, and capability. Cloud computing is deployed by NCBI and will continue to expand as a platform to supplement on-premises computing in order to scale storage and compute demands driven by the exponential growth in protocol and results data.

2.0 BACKGROUND

The National Library of Medicine (NLM), on the campus of the National Institutes of Health

(NIH) in Bethesda, Maryland, has been a center of information innovation since its founding in

1836. As the world’s largest biomedical library, the NLM maintains and makes available a vast print collection and produces electronic information resources on a wide range of medical and biological research topics that are searched billions of times each year by millions of people around the globe. It also supports and conducts research, development, and training in biomedical informatics, computational biology, and health information technology. The NLM's goal is to educate the current and next generation of innovators in biomedical informatics and data science, and, in addition to creating and disseminating databases covering a wide range of the biomedical bibliographic and genomic sequence space, its researchers develop gene analysis techniques, devise creative ways to search and analyze medical images, and apply advanced analytics to decode clinical narratives. In essence, the NLM looks to apply advanced analytics to addressing the public health and basic genomic research needs.

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The NLM envisions a future in which data and information transform and accelerate biomedical discovery and improve health and health care. Achieving this vision will require the NLM to focus and enhance its research, development, training, and information services to make more biomedical data findable, accessible, interoperable, and reusable (the FAIR principles), to invent the tools and services to turn data and information into knowledge and insight, and to develop the workforce capable of doing so. It will require new forms of partnership and engagement with stakeholders in the public and private sectors, including researchers, librarians, health professionals, entrepreneurs and innovators, underserved communities, and the public.

Within the NLM, the National Center for Biotechnology Information (NCBI) was established by

Public Law 100-607 in November 1988 as a division of the NLM. The NCBI was given the following statutory responsibilities: (a) to design, develop, implement and manage automated systems for the collection, storage, retrieval, analysis and dissemination of information about molecular biology and genetics; (b) to perform research into advanced methods of computer-based information processing for analyzing the structure and function of biologically important molecules; and (c) to coordinate the gathering of biomolecular information both nationally and internationally.

To carry out its mandate, the NCBI:

1. Conducts basic and applied research on fundamental biomedical problems at the molecular level using mathematical and computational methods.

2. Maintains scientific collaborations with the National Institutes of Health (NIH) institutes, academia, and other governmental agencies and international organizations.

3. Fosters the application of advanced computing technologies through state-of-the-art analysis tools and comprehensive and expertly annotated databases.

4. Coordinates access to a variety of databases and software for the scientific and medical communities.

5. Develops and promotes standards for data deposition and exchange, and biological nomenclature.

The NCBI is specifically charged with building and providing public access to databases and search services vital to the medical and molecular biology communities and of key interest to the public as well. As part of the NCBI’s mission to collect, annotate and distribute all publicly available DNA sequences, it is a key repository for major large-scale sequencing projects and is actively involved in assembling and annotating the sequence data they produce.

Given its central role in genomic research, and the continuing need to make rapid advances in bioinformatics and computational biology, the NCBI has been charged with taking on special projects related to facilitating discovery, learning and advancements in areas of immediate interest such as surveillance of viruses and other pathogens, and areas that impact broad communities of the general public as well as researchers and medical professionals. These projects involve providing the next generation of tools and methods to the research community, facilitating their use and usefulness, as well as learning from an extensive engagement with the research community, and in turn translating the science to the health community and the public.

Projects range from modernizing methods of data search and retrieval, gene annotation, SOW: Page 3 of 49 evaluation of sequence quality, and comparative analyses, to developing new data infrastructures, user interfaces, and tools to result in an improved experience for the public.

ClinicalTrials.gov is an important NIH enterprise system, maintained by the NCBI, that serves a critical role in providing the NIH, researchers, the public, and others with up-to-date clinical research information. Such information has been reinforced during the COVID-19 pandemic.

Congress mandated in 1997 that NIH create and maintain ClinicalTrials.gov. It reemphasized the importance of the system in 2007 by expanding NIH’s mandate to accept information from a broader set of clinical trials and include summary trial results information, and by empowering the Food and Drug Administration (FDA) to enforce compliance with data submission requirements. Public expectations and support related to clinical trial transparency have led to passage of other laws, regulations, and policies requiring registration and results reporting in

ClinicalTrials.gov. These include regulatory requirements issued in 2016 and an NIH policy issued in the same year that establishes an expectation that all NIH-funded clinical trials be registered and have results reported to ClinicalTrials.gov. This NIH policy is one component of

NIH’s broader efforts to enhance stewardship of NIH-funded clinical trials and to improve both accountability and transparency.

ClinicalTrials.gov provides patients, family members, health care professionals, researchers, and other members of the public with convenient access to information on clinical studies for a wide range of diseases and conditions. As of July 2024, ClinicalTrials.gov has over 500,000 registered clinical studies sponsored by the NIH, other Federal agencies, non-profit organizations and private industry. More studies are added daily and an average of 850-1,200 studies are added per week. Studies listed in the database are conducted in all 50 states and in over 220 countries. ClinicalTrials.gov also includes a results database with results information for completed studies. The web site lists over 65,000 studies with results and 350 – 450 new results submissions are added per week. ClinicalTrials.gov hosts approximately 100,000 visitors daily.

Clinical study information is submitted by sponsors responsible for conducting clinical trials, governmental or international agencies conducting clinical trials, and principal investigators who are responsible for conducting and coordinating the overall clinical investigation. To facilitate this, the NLM has developed the Protocol Registration and Results System (PRS)

(http://clinicaltrials.gov/ct2/manage-recs/register ), a Web-based tool for submitting information to ClinicalTrials.gov. Information may also be transferred electronically to ClinicalTrials.gov through the PRS as an HTTP upload of an XML formatted file. Registered data providers enter information about their clinical trials, ensuring that the information is accurate, readily understood by members of the public, and updated in a timely manner. They serve as a point of contact for the ClinicalTrials.gov team and resolve questions associated with the information that is provided. NLM operates the PRS and the ClinicalTrials.gov website and administers a process to help ensure that records meet minimum quality control standards.

The criteria by which records are reviewed are described in the Protocol and Results Review criteria documents:

http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf and http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf .

http://clinicaltrials.gov/ct2/manage-recs/register http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf

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3.0 OBJECTIVE

The objective of this requirement is to support NCBI’s efforts to accomplish its mission of providing patients, their family members, health care professionals, researchers, and the public community with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions and within a timely manner.

4.0 SCOPE

The scope of this Task Order is to acquire complex professional specialized expertise, some of which is Information Technology (IT) services, to support the operations, maintenance, and modernization of ClinicalTrials.gov. In addition, the specialized expertise is required by NCBI to address and support the following NLM strategic objectives:

Accelerate discovery and advance health through data-driven research

• Interconnect the resources of the NCBI/NLM digital information enterprise

• Advance research and development in biomedical informatics and data science

• Create a sustainable institutional and computational infrastructure

Reach more people in more ways through enhanced dissemination

• Support research in biomedical and health information access methods and information dissemination strategies

• Enhance information delivery through analytics-driven user engagement

Help build a workforce for data-driven research and health

• Assure data science and open science proficiency

• Increase workforce diversity

Non-It Portion of the Work Requirements:

The Contractor shall be responsible for data quality control and related processes. This includes, but is not limited to: (1) review of individual records for apparent errors, deficiencies, internal consistencies (e.g., overall trial status must be consistent with status of individual locations; data in age field must agree with information in narrative description; analysis populations are consistent across results modules); (2) timeliness (i.e., contractor shall review dates and prompt data providers for updated information); (3) use of correct terminology; and (4) use of appropriate and understandable language.

It is essential to NLM that these activities be performed with a high degree of technical and scientific accuracy. The contractor shall possess appropriate scientific, medical, and clinical trials knowledge as well as expertise in data abstraction, data entry, data validation, the application of NLM’s Medical Subject Headings (MeSH), a widely used medical controlled vocabulary, and overall review process management.

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In conjunction with NLM staff, the Contractor shall document issues in records and work with data providers to resolve problems and correct records. The Contractor shall support data providers in resolving review issues and guiding them through the data submission process, if such support is required by individual data providers. The Contracctor shall report all problems or inconsistencies to the NLM Task Manager as they are discovered.

IT Portion of the Work Requirements:

The contractor shall also provide comprehensive software design and engineering, system administration, and other ancillary IT support that NCBI requires for the continued growth and evolution of ClinicalTrials.gov databases and information systems. The scope of the design and development work will encompass the final stages of re-engineering, modernization, and long-term maintenance of the ClinicalTrials.gov and PRS database systems to improve their performance, reliability, and capability.

To successfully accomplish the The ClinicalTrials.gov software support effort, the Contractor shall possess expertise in modernization of a legacy data submission system, written in Java, high-performance computing, including cluster/scale-out, data structures and algorithms;

programming in Java, and Kotlin for backend software, TypeScript/JavaScript for front-end programming; automated testing; knowledge of high-performance data storage techniques and databases; and DevOps experience using latest techniques of CI/CD and automated deployments.

ClinicalTrials.gov Modernization: A modernization of the IT infrastructure is nearing completion to ensure that ClinicalTrials.gov provides the necessary flexibility to meet the growth in the number of clinical trials, in new protocols and in results reporting. This project focused on collecting and validating user requirements, modernizing core infrastructure and cybersecurity models, and implemented modern technical approaches in design, development and delivery.

This special project maximized the value of ClinicalTrials.gov to the clinical research ecosystem, including NIH Institutes and Centers, FDA, and a broad range of users such as patients, healthcare providers, trial sponsors, and researchers. The effort is transitioning to a new database. The IT support is required to re-engineer and modernize key system components to improve performance, reliability, and capability concluding the reliance on the legacy system.

In summary, the Contractor’s expert IT services provided under this Task Order will enable the

ClinicalTrials.gov to continue to accomplish its mission of providing patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Consequently, the software development and computer support to be provided under this SOW spans a wide spectrum of data sources, serves both a specialized as well as a broad community of users, and must be responsive to the rapidly evolving fields of clinical trials data. The software support required in this SOW is not a set of commodity services or skills. Rather, it is programming and design skills that can match the progress of cutting-edge research to deliver analytic tools and databases in an agile and science-driven environment.

As initiatives develop or change, additional Tasks may be required through collaboration and coordination between the Contractor Officer’s Representative (COR), NCBI Scientific

SOW: Page 6 of 49 and Senior Leadership, and the Contractor. The Contractor shall be flexible in adopting new projects and adapting to last minute changes in project scope and direction.

Subject to prior approval of the Contracting Officer (CO), the Contractor may acquire the services of a subcontractor and/or consultants to provide specialized services if deemed by the COR to be appropriate and within scope.

5.0 SOW TASKS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform individual Task Assignments at the direction of the COR within the SOW Tasks specified below.

Each Task Assignment issued to the Contractor shall directly support NCBI’s efforts to operate, maintain, and modernize ClinicalTrials.gov and directly support ClinicalTrials.gov curator experts and NCBI’s software and technical support services requirements specified under this

SOW. Contractor expertise required to successfully accomplish Task Assignments under this

SOW include advanced degrees in biology, research, physics, engineering, information technology, computer science, mathematics, bioinformatics. or similar fields.

5.1 SOW TASK 1 – TASK ORDER MANAGEMENT (Non-IT Services) (Firm-Fixed-

Price)

The Contractor shall provide the technical and functional activities at the Task Order level necessary for successful program management of this SOW. The Contractor shall employ a technical approach, organizational resources, and management controls to achieve cost, schedule, and performance requirements throughout the execution of the Task Order.

The Contractor shall be responsible for providing, managing, and overseeing its personnel as well as any subcontractor/consultant efforts used in the performance of the Task Order.

The Contractor shall provide all necessary management oversight to ensure that the Task Order is performed efficiently, accurately, on time, within scope and budget, and in-compliance with the requirements of this document and all modifications. The Contractor shall provide an overall management organizational and communication structure to provide collaborative, responsive interfacing with the Government and implement such a structure subject to the Government’s approval. The contractor management organization shall address all contract and staffing-related issues at the lowest effective level without unnecessary escalation, while preserving clear paths to senior management to address operational problems.

In coordination with the COR, the Contractor shall perform all the necessary centralized administrative, clerical, documentation, budgeting, auditing, analysis, and other related functions for supporting the Task Order Management.

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The NIH operates under a hybrid workplace that provides its employees with flexible work schedules and remote workplaces. While flexible work schedules and working remotely generally translate into higher productivity for the organization, there are also challenges to management that must be overcome relative to workplace expectations. The Contractor shall effectively manage a staff performing in a hybrid workplace under the Task Order.

Task Order Management Plan: The Contractor shall prepare a written Task Order

Management Plan outlining management approaches, automated tools to be used, key activities to be performed, and deliverable dates for products required by this SOW. The Plan shall be delivered in draft not later than two weeks following the award of the Task Order.

It is the responsibility of the Contractor to review and identify progress on outstanding Task

Assignments and to notify the COR when deviations from planned timelines are discovered.

Monthly Activity and Financial Status Reports: The Contractor shall provide separate monthly activity and financial status reports that monitor the progress, cost, schedule, quality assurance, configuration management, and security management as applicable to the Task

Assignments issued under this SOW. The reports shall include, but not be limited to, all the following:

• Cost accounting by Task Assignment and by each labor category

• Level of effort reporting by each employee and Task Assignment

• Costs associated with subcontractors, consultants, or other teaming arrangements

• Burn rate analyses for up to length of current Task Order period

• Employee on-boarding/off-boarding information

• Visa processing status of pending candidates

• Status of recruiting efforts

• Detailed description of Other Direct Costs (ODCs)

• Listing of company-provided training

• Updates on employee resumes, specifically, certifications or other educational achievements

Although the activity and financial status reports are due monthly, this shall not relieve the

Contractor of the responsibility to proactively keep the Government informed of issues or problems as they occur (including technical, cost, or schedule issues) or to respond to COR requests which may require immediate action.

Other Reports: The Contractor shall provide other reports pertaining to the Contractor’s performance under the Task Order, as requested by the COR.

The Contractor’s Program Manager shall also meet with the COR and NLM Task Manager on a regular basis and provide verbal activity and financial status reports, including status of individual Task Assignments as requested. On occasion, the Contractor’s Project Leads may be required to meet with the COR or other government officials to collaborate or coordinate Task

Assignments.

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Bi-weekly Reports of Contractor Staff Leave Schedules: The Contractor shall provide weekly reports in a computer-readable format of Contractor staff leave schedules to enable the

Government to be notified of anticipated absences and vacation schedules.

5.2 SOW TASK 2 – SUPPORT FOR CLINICALTRIALS.GOV OPERATIONS AND

MAINTENANCE (Non-IT Services) (Time & Materials)

The Contractor shall provide quality control of data and processes, and related services, to NLM to ensure that submitted data meet quality standards for posting on ClinicalTrials.gov. It is essential to NLM that all of these activities be performed with a high degree of scientific accuracy. The requirements shall include, but not be limited to, all the following:

• Perform quality assurance assessments of the protocol registration records (including study documents) submitted to the ClinicalTrials.gov database.

• Perform quality assurance assessments of results records (including study documents) submitted to the ClinicalTrials.gov database.

• Provide ongoing maintenance of records in the PRS.

• Implement and maintain standard operating procedures (SOPs) and review guidelines for reviewer tasks and review criteria.

• Provide timely recommendations for improving protocol and results review policies and procedures, including additional automated business rules and standard comments to augment system.

• Provide business analysis support in the following domains: organizational, business processes, data analysis, information technology, systems analysis, and usability analysis.

• Monitor data for trends or patterns of problems (e.g., consistent series of errors from multiple data providers or a single data provider) and notify the NLM Task Manager when patterns arise.

• Provide specific recommendations for additional guidance to the user community to help prevent recurring problems.

• Develop and support the maintenance of training and other resources for data providers submitting information to the PRS and for the public using the ClinicalTrials.gov website.

• Serve as a liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov and contract staff.

• Provide communications internally and externally via automated means provided by the

NLM (PRS; current email system Microsoft Outlook; teleconference).

• Provide reports on a weekly basis, or as requested, using the PRS and ClinicalTrials.gov.

Provide reports to NLM with comprehensive information such as status, errors, and trend analyses.

• Conduct research, as directed, on content within and external to the ClinicalTrials.gov database including, but not limited to, evaluation of best practices in reporting the results of clinical research.

• Conduct protocol record reviews within 2 to 5 business days and results reviews within 30 calendar days of submission.

• Review New Account Applications received in the PRS and create new accounts for valid organizations, according to established internal review criteria. Applications should generally be reviewed within 1 to 2 business days.

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• Review and reply to emails from data providers and the public, as directed.

• Identify subject matter experts and provide training for new reviewers and ongoing in-service updates for existing protocol and results team reviewers.

• Collect, review and file documents that are related to records in the PRS (e.g., Human

Subject Review Board Letters).

• Support the conduct of training workshops, expert meetings, conferences, and web-based training.

The Contractor shall perform administrative and other related activities to support NCBI and the

ClinicalTrial.gov team. The requirements shall include, but not be limited to, all the following:

• Provide administrative support primarily to the NCBI Director, but also to other team members.

• Perform other administrative activities including, but not limited to, scheduling meetings, making travel arrangements, preparing emails, answering phone calls, taking meeting summaries, supporting all-hands meetings, assisting the NCBI Director with office assignments, filing, and photocopying.

The Contractor shall perform communications and editorial activities to support NCBI and the

ClinicalTrial.gov team. The requirements shall include, but not be limited to, all the following:

• Provide technical writing and editorial support for all content and education materials related to materials for data providers and information posted on the ClinicalTrials.gov website, and for writing in plain language.

• Provide evaluation of existing resources, make recommendations for enhancing and updating existing resources, and assist in the development of additional resources. Such content may be web or print based and examples of information include web-based tutorials, glossaries, fact sheets, frequently asked questions and answers. Increase transparency of ClinicalTrials.gov resources to reflect diversity across the clinical trial ecosystem.

• Provide graphic support, social material images, copy/edit of presentation and making materials Revised Section 508 compliant.

• Regularly review posted content for currency and consistency with the Style Guide and copy edit support for new and existing content.

• Provide assessments of new and existing content for consistency with Revise Section 508 standards which requires that web site content be equally accessible to people with disabilities and diverse populations.

5.3 SOW TASK 3 – ONGOING TECHNICAL SUPPORT FOR

CLINICALTRIALS.gov (IT Services) (Time & Materials)

In support of its mission, NCBI has an ongoing requirement for software and systems engineers and other staff to provide technical support for ClinicalTrials.gov projects. The requirements shall include, but not be limited to, all the following:

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• Ensure the website is updated in a timely manner utilizing tools such as JIRA for tracking work.

• Perform phased development via incremental software/hardware development approaches, building on the infrastructure that supports NCBI’s existing web-based database and information delivery system.

• Work with relevant data formats and encodings, HL7/FHIR specifications.

• Assist with automation support.

• Analysis of requirements and development of systems for curation and management of large data sets.

• Support development of ClinicalTrials.gov relational databases.

• Support of the Machine Learning models for PRS automation.

• Support of the ClinicalTrials.gov public site frontend and backend.

• Support of the ClinicalTrials.gov PRS frontend and backend.

• Support of the ClinicalTrials.gov reporting system.

• Provide a comprehensive system engineering process to specify, design, develop, integrate, test, produce, deliver, verify, validate, document, and sustain the system/software that:

o Supports rapid, cost-effective development/modification of the operational system.

o Mitigates the risk associated with technology obsolescence and proprietary technologies.

o Develops solutions within an Open-Source environment for widespread distribution to the research community.

o Ensures interoperability with the modernized PRS and transition from the existing database.

o Reduces system life-cycle cost and logistics footprint by addressing required quality attributes, such as reliability, maintainability, security, and human factors.

o Supports rapid, cost-effective modification upgrade/technology insertion.

o Operates within the dev/ops, CI/CD, UI/UX framework employed at NCBI/NLM.

o Ensures 99.5% uptime and availability of the website and trouble shoots as needed.

• Provide an effective system/software development and integration process that:

o Uses a modular Open-Systems architecture approach and Agile techniques.

o Uses effective contractor management processes, procedures, systems, internal metrics, and performance measures unless their use conflicts with contract requirements or does not allow contract requirements to be completely met.

o Uses scientific data management, including data collection, workflow analysis, entry, verification, maintenance, and dissemination.

o Uses development of high-performance, database-driven search and retrieval applications in the web environment.

o Implements and uses electronic information systems on cloud-based infrastructure technologies, including AWS, Azure, Google Cloud Platform.

o Integrates, uses, and administers software-as-a-service solutions that support the operations of NCBI.

• Perform Web usability testing and design of ClinicalTrials.gov and the Protocol

Registration System for ongoing operations of the system.

• Provide ongoing support and consultation when needed to ensure that the design, layout, and organization of the site are intuitive and user-friendly. Rely on research-based Web

SOW: Page 11 of 49 design and usability methodologies and guidelines to guide these efforts. For example:

usability engineering, an evidenced-based methodology that involves end users in the design and testing process to produce information systems that are measurably easier to learn, remember, and use. The scope of the project may include: user and task observation and analysis, data collection and analysis, information architecture and graphic design, and iterative usability testing of new designs.

• Optional: Time-limited project: Provide support for the ongoing migration to secure federated sign on and 2 factor authentication log-in processes into the PRS.

5.4 SOW TASK 4 – MODERNIZATION SUPPORT FOR CLINICALTRIALS.gov (IT

Services) (Time-and-Materials)

5.4.1 Upgrade and Modernize the Protocol Registration and Results System (PRS)

All major projects have designated Project Owners responsible for general oversight and for task prioritization. Using principles established by the Agile Manifesto as well as NCBI’s adoption of Scrum, there are a number of aspects to Agile development that will provide the Government with a project management structure that will ensure contractor performance is monitored and issues are immediately addressed. The Contractor shall conduct testing and other user research methods at regular intervals throughout implementation fo new or remaining modernization features (not just at the beginning or end), with all electronic artifacts from usability testing and/or other research methods with end-users being made available at the end of every applicable sprint. This contracted support fulfills the need to supplement the resources for particular phases of the implementation driven by programmatic and executive decisions by NCBI management.

The following is a representative list of modernization support Task Assignments that the

Contractor shall perform:

• Perform software analysis, design and development assignments.

• Perform Web design and usability assignments that meet requirements for Revised

Section 508 compliance. Assignments include graphic design, data visualization and user-centered design techniques; including design and development of user interfaces based on user needs analyses (including diverse populations) and design prototyping and evaluation.

• Conduct research activities using modern methodologies, including stakeholder interviews and usability tests. Contractor must create and deliver records and notes collected during their research and assist with any relevant documents to support OMB clearance for collection of information.

• Work with NCBI AppSeq team to ensure that the system is compliant with security policies.

• Provide support in executing product roadmaps and rollout.

• Provide overall project management support.

• Communicate hiring and staffing status.

• Participate in requirements and user feedback analysis.

• Study existing applications, data formats, development environment and practices, production infrastructure.

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• Participate in story mapping exercises.

• Estimate staffing resources and timelines of tasks for technical implementation and delivery.

• Develop architecture and designs for cloud-based databases, processing pipelines and web applications.

• Develop application modernization and data migration strategies.

• Design and implement secure high availability solutions.

• Design and implement CI/CD pipelines, automayed testing and deployment with NCBI

DevOps team.

• Implement software components for cloud-based web applications.

• Implement client components for Angular JavaScript-based web applications.

• Creat required technical documentation.

• Work with ClinicalTrials.gov and NCBI Systems teams to develop operational procedures, documents (such as Run Books) for Operation and Maintenance of the developed modernized software.

• Ensure that the architecture is extensible to allow for further development, including integration with compatible internal or external systems.

• Program using Java, Kotlin and Python in a predominantly Linux application development environment, including Windows and MacOS environments.

• Develop Web-based applications using JavaScript, CSS, XML, XSLT, and HTML in a cross-browser environment.

• Develop database applications using MySQL and other relational databases.

• Develop emerging applications using NoSQL databases, e.g., MongoDB, Cassandra and file-based indexers, e.g., Elasticsearch.

• Perform software testing and quality control employing automated testing environments and configuration management.

• Design and maintain databases and applications for clinical trials data.

• Use various commercial cloud services, including GCP and AWS in following configurations:

o Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a

Service (SaaS).

• Use secure coding practices, particularly where those practices impact development of information systems that meet FISMA requirements and comply with NIH/NLM security assessment and authorization frameworks.

• Provide relevant and specialized project support from disciplines such as computer science, machine learning, and program management.

• Perform DevOps for CI/CD/Service Management/Monitoring using tools such as build

(TeamCity, Jenkins), cluster schedulers (Nomad, Kubernetes), service mesh (Linkerd, Istio), and monitoring (TIG stack).

• Deliver detailed a project work plan for completing the sprints and a dedicated scrum master to keep the project moving in a timely manner.

• Assist the User Experience Research and Design UI/UX teams for (Public Site and PRS) to complete the following tasks:

• Deliver testable prototypes of new screens, support for HTML/CSS, and features aimed to improve the PRS upgrades.

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• Deliver testable prototype of tools or features that aid in simplifying the information submission process.

5.4.2 Trailing (Enhancement) Transition Costs (Optional)

The Contractor shall perform, as required, software testing and quality control employing automated testing environments and configuration management.

5.5 SOW TASK 5 – SUBJECT MATTER EXPERT AND RESEARCH SUPPORT

FOR CLINICALTRIALS.gov (IT Services) (Time-and-Materials)

The Contractor shall provide scientists, programmers, and technical experts with the necessary expertise to participate in and support basic and applied research in fields of interest to NCBI, such as machine learning, FHIR API and text retrieval.

The field of clinical research is quickly and constantly evolving. The ClinicalTrials.gov registry and results database must keep current with new practices in order to accurately capture current research protocols and subsequent findings. The Contractor, as required, shall provide subject matter experts who can provide specific and general feedback on modifications that may need to occur in the PRS or the public web site to adapt to these changes. The Contractor’s subject matter experts shall, as required, perform systematic evaluations of specific scientific or technical issues to better inform any related recommendations. The Contractor shall deliver all findings to ClinicalTrials.gov in the form of a report, and if relevant, submitted for publication in a biomedical or related journal.

5.6 SOW TASK 6 – TRANSITION PLAN (Non-IT Services) (Time & Materials)

Prior to completion of the Task Order’s period of performance, the Contractor shall provide the

Government with a Transition Plan that shall ensure an orderly and successful transition of the remaining task assignments to a successor contract. As part of the Transition Plan, the

Contractor shall transition all knowledge and completed, or in process, material in sufficient detail to ensure ongoing performance of the requirements specified in this SOW.

6.0 TASK ORDER TYPE

Ths Task Order is a hybrid (combination of) Firm-Fixed-Price (FFP) and Time-and-Materials.

[Reference Federal Acquisition Regulation (FAR) 16.202 & 16.601] Under the Task Order, all

Task Assignments shall be issued by the COR.

All Task Assignments issued under SOW TASK 1 shall be FFP (FAR 16.202).

All Task Assignments issued under SOW TASKS 2, 3, 4, 5 and 6 shall be T&M (FAR 16.601).

7.0 PERIOD OF PERFORMANCE

This requirement consists of a 12-month Base Period with two 12-month Option Periods for a

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8.0 PLACE OF PERFORMANCE

The Contractor shall perform limitedwork described herein at NIH Federally-controlled facilities in Buildings 38A and 45 on the NIH Campus in Bethesda, Maryland. The Contractor may perform a most of the workwork at its Non-Federally-controlled facility, including work conducted under an official NIH remote work policy, subject to approval in advance by the COR. The Contractor shall perform project management and administrative support at its Non-Federally-controlled facility.

9.0 DELIVERABLES/DELIVERY SCHEDULE

All deliverables shall be in accordance with the specifications and “Deliverables/Delivery

Schedule” provided below, and as further supplemented in Task Assignments issued.

At the request of the COR, the Contractor shall provide deliverables, including reports, presentations to federal staff, and other materials, in draft form for Government review and comment and in final form, conforming to schedule, format, and other requirements as specified by the COR. In addition to monthly status reports, deliverables may include project plans, management briefings, other financial reports, analyses, evaluations, reviews, and other reports as required. Additional reports may be requested by the COR at any time during the period of performance.

The Contractor shall provide the following deliverables for review and acceptance by the COR.

Deliverable

SOW

Provision Due Date

Kickoff Meeting 5.1 As specified by the COR.

Task Order Management Plan (written draft) 5.1 In draft not later than 14 calendar days following award of the Task Order.

Task Order Management Plan (written final) 5.1

No later than five (5) days following the timely receipt of comments from the

COR

Monthly written status reports 5.1 On a date per month as specified by the

COR.

Deliverables specified in each Task

Assignment

5.2

Thru

5.5

As directed by the COR.

Transition Plan 5.6 As directed by the COR.

Baseline Security Requirement - Roster of

Employees Requiring Suitability Investigations 12.0

Initial submission - within 14 calendar days of the effective date of the Task

Order.

Subsequent submissions - within 14 calendar days of any revision to the

Roster as a result of staffing changes.

Baseline Security Requirement - Contractor

Employee Non-Disclosure Agreement (NDA) - 12.0

A copy of each signed and witnessed

NDA shall be submitted to the COR and

SOW: Page 15 of 49

Deliverable

SOW

Provision Due Date

Commitment to Protect Non-Public

Information – Contractor Employee Agreement

CO prior to performing any work under the Task Order.

Training records for all mandatory training 12.0 In conjunction with Task Order award and annually thereafter or upon request.

Rule of Behavior – signed document for each employee 12.0

Initiation of Task Order and at least annually thereafter.

Incident Response Report (as incidents occur) 12.0 Within 1 hour of discovery of incident.

Incident Response Plan 12.0 Upon request from the COR.

Personal Security – List of employees with defined roles and responsibilities 12.0

Within 14 calendar days before an employee begins working under the

Task Order.

Personal Security – Off-boarding documentation, equipment and badge when terminating work under the Task Order

12.0

Within 14 calendar days after the

Government’s final acceptance of the work under the Task Order, or in the event of a termination of the Task

Order.

Badges - all badges shall be submitted to the COR within two (2) business days after the Government’s final acceptance of the work under the Task

Order, or in the event of a termination of the Task Order.

Fingerprinting 12.0

All contractor (including any subcontractor) employees shall have a successfully adjudicated fingerprint check before gaining access to HHS-controlled information systems.

Background Investigation – On-boarding documentation when beginning work under the

Task Order

12.0 Prior to performing any work on behalf

of NIH.

Revised Section 508 Reporting Requirements 20.0 As required

Accessibility Conformance Report (ACR) 20.0 As required

Continuity of Operations During a Government

Closure Plan

26.0 As directed by the COR

All documents required herein shall be submitted in electronic format.

Requirements for accessibility based on the Revised Section 508 Standards of the Rehabilitation

Act of 1973 (29 U.S.C. 794d) are determined to be relevant under this SOW for the Section 508

Criteria specified in the attached Accessibility Requirements Tool (ART).

Before acceptance, when the Contractor is required to perform testing to validate conformance to the Revised Section 508 accessibility requirements as specified in a Task Assignment issued under this SOW, the Contractor shall provide a Supplemental Accessibility Conformance Report

(SAR) that contains the following information:

• Accessibility test results based on the required test methods.

• Documentation of features provided to help achieve accessibility and usability for people with disabilities.

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• Documentation of core functions that cannot be accessed by persons with disabilities.

• Documentation on how to configure and install the Information and Communication

Technology (ICT) item to support accessibility.

• When an ICT item is an authoring tool that generates content (including documents, reports, videos, multimedia productions, web content, etc.)., provide information on how the ICT item enables the creation of accessible electronic content that conforms to the

Revised 508 Standards, including the range of accessible user interface elements the tool can create.

• Before final acceptance, the contractor shall provide a fully working demonstration of the completed ICT Item to demonstrate conformance to the agency's accessibility requirements. The demonstration shall expose where such conformance is and is not achieved.

Before acceptance of deliverables under any Task Assignment issued under this SOW, the

Government reserves the right to perform independent testing to validate that the ICT solution provided by the Contractor conforms to the applicable Revised Section 508 Standards.

Before final acceptance of any ICT item, including updates and replacements, if the Contractor claims its products or services satisfy the applicable Revised Section 508 Standards specified in the SOW, and the Contracting Officer determines that any furnished ICT item is not in compliance with such requirements, the Contracting Officer will promptly inform the Contractor in writing of the noncompliance. The Contractor shall, at no cost to the agency, repair or replace the non-compliant products or services within the period specified by the Contracting Officer.

Electronic documents delivered shall be made available in alternate formats when requested by the COR, including formats compatible with assistive technology, at no additional charge.

10.0 FIRM-FIXED-PRICE/TIME-AND-MATERIALS (ESTIMATED – NOT TO

EXCEED)

The Government estimates the following resources in the performance of this SOW but the

Contractor has the ability to propose a staffing plan that best meets the needs of the requirement:

ESTIMATED LABOR HOURS (1 FTE = 1920 Hours)

Time-and-Materials (T&M)

(Estimated – Not to Exceed)

Labor Categories

Quantity Type

(Base/Optional)

Base Period

Option

Period 1

Period 2

Total

Labor

Hours

Non-IT Services (Tasks 2 & 6)

SME I (Junior) BASE 19,200 19,200 19,200 57,600

SME II (Mid-Level) BASE 28,800 28,800 28,800 86,400

SME III (Senior) BASE 16,800 16,800 16,800 50,400

IT Services (Tasks 3, 4 & 5):

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Programmer/Analyst BASE 28,800 7,680 7,680 44,160

Systems/Software Engineer BASE 23,040 7,680 7,680 38,400

Programmer/Analyst OPTIONAL 11,520 34,560 23,040 69,120

Total: T&M Labor 128,160 114,720 103,200 346,080

Materials (including Other

Direct Costs)* $30,000 $30,000 $30,000 $90,000

Firm-Fixed-Price (FFP)

Labor Categories

Period 1

Option

Period 2

Total

Labor

Hours

Non-IT Services (Task 1):

Program Manager BASE 7,162 7,162 7,162 21,486

Total: FFP Labor 7,162 7,162 7,162 21,486

TOTAL EFFORT – T&M and FFP

Option

Period 1

Option

Period 2 Total

Total IT Services (Tasks 3, 4, & 5)

BASE/OPTIONA

L 63,360 49,920 38,400 151,680

Total Non-IT Services (Tasks

1, 2, & 6)

BASE 71,962 71,962 71,962 215,886

GRAND TOTAL:

135,322 121,882 110,362 367,566

T&M and FFP Labor

Materials (including Other

Direct Costs)* $30,000 $30,000 $30,000 $90,000

*Materials as defined pursuant to Federal Acquisition Regulation (FAR) 16.601 (e.g., subcontracts, parking fees, direct materials, training, travel, and other direct costs that have received prior written approval from the COR). All travel incurred in performance of the Task Order shall adhere to Federal Travel Regulation guidelines prescribed by the General Services Administration (GSA).

11.0 LABOR CATEGORIES

The following labor categories are proposed to successfully perform the work requirements under this SOW.

Due to the continuing evolution of NCBI’s responsibilities for the data integration of NLM’s specialized genomic, genetic, chemical and literature databases; it is understood that additional labor categories may need to be incorporated into this SOW, subject to approval by the

Government, in order to accomplish the Tasks specified in Provision 5.0 above.

SOW: Page 18 of 49

11.1 Program Manager

11.2 SME I

Minimum/General Experience: 6 years of relevant experience.

Functional Responsibility: Responsibilities will vary but may include any of the following or similar: Serve as subject matter expert in a functional, technical, scientific, academic, regulatory, operations, government mission, or other specialty area. May advise the project team or client organization in specific areas of expertise. Participate as needed across project phases. Apply principles, methods, and knowledge towards the project approach, deliverables, reports, representations, or quality control. This labor category may be applied to non-technical roles required as part of the overall project. Minimum Education: Bachelor's Degree.

11.3 SME II

Minimum/General Experience: 8 years of relevant experience.

Functional Responsibility: Responsibilities will vary but may include any of the following or similar: Serve as subject matter expert in a functional, technical, scientific, academic, regulatory, operations, government mission, or other specialty area. May advise the project team or client organization in specific areas of expertise. Participate as needed across project phases. Apply principles, methods, and knowledge towards the project approach, deliverables, reports,

11.4 SME III

Minimum/General Experience: 15 years of relevant experience.

Functional Responsibility: Responsibilities will vary but may include any of the following or similar: Serve as subject matter expert in a functional, technical, scientific, academic, regulatory, operations, government mission, or other specialty area. May advise the project team or client organization in specific areas of expertise. Participate as needed across project phases. Apply principles, methods, and knowledge towards the project approach, deliverables, reports,

11.5 Programmer/Analyst

Minimum Education: Minimum of 2 years experience. Knowledge of at least two higher-order programming languages. Must be familiar with various commercial software packages.

F…